Kornimate/medical-research-clean huggingface dataset:
adding different additives to bupivacaine-fentanyl mixture in spinal anesthesia for cesarean section

Conditions: Postoperative Pain

Summary: spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. to reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.

spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. to reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.many augmentation strategies for intrathecal analgesia have been proposed. a meta-analysis by popping et al. concluded that the concomitant use of an opioid such as fentanyl intrathecally allows the reduction in the dose of local anesthetic, while augmenting its analgesic potency thereby decreasing its adverse effects. dexamethasone relieves pain through reducing inflammation and blocking of nociceptive c- fibers transmission and by suppressing neural ectopic discharge. post-operative analgesic effectiveness and duration was prolonged when dexamethasone was used as an adjunct for peripheral nerve blocks. recent studies reported no complications associated with intrathecal dexamethasone. dexmedetomidine (dex) is a potent, selective α2 adrenergic agonist and when given intrathecally, it exerts its analgesic effect via stimulating spinal α2 receptors. wu et al., in their meta-analysis showed that addition of intrathecal dex significantly increased the duration of postoperative analgesia and reduced analgesic consumption. the increase in duration of postoperative analgesia is dose dependent but with increase in the incidence of bradycardia.

Eligibility criteria:
inclusion criteria: * 90 parturient * the statue of american society of anesthesiologists' physical class ii * prepared for an elective cesarean section. exclusion criteria: * bmi \> 35kg/m2 * gestational age \< 28 weeks * diabetes or gestational diabetes * hypertension or pre-eclampsia * contraindications to spinal anesthesia * height less than 160 cm * history of psychiatric disease * taking α-receptor antagonist drugs -a history of allergy to the study drugs- * excessive hemorrhage needing transfusion.
ofatumumab as front-line therapy in treating elderly participants with chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: this phase ii trial studies how well ofatumumab works as front-line therapy in treating elderly participants with chronic lymphocytic leukemia. monoclonal antibodies, such as ofatumumab, may interfere with the ability of cancer cells to grow and spread.

primary objectives i. to evaluate the overall response rate of ofatumumab in the upfront setting in elderly, unfit patients with chronic lymphocytic leukemia (cll). secondary objectives: i. to determine the overall survival with ofatumumab in upfront setting in elderly, unfit cll patients. ii. to evaluate the complete response rate and time to progression to therapy of ofatumumab in elderly, unfit patients with cll. iii. to determine the plasma levels of ofatumumab in elderly, unfit patients. iv. to evaluate predictive capability of micro ribonucleic acid (rna) (mirnas) detection in plasma samples. outline: participants receive ofatumumab intravenously (iv) over 4 hours once a week for 4 weeks, then monthly thereafter. treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * patients with chronic lymphocytic leukemia requiring treatment at the time of signing informed consent. * eastern cooperative oncology group (ecog)/world health organization (who) performance status of 2-3 and a cumulative illness rating scale (cirs) or charlson co-morbidity score of 2 or higher. * creatinine \< 2mg/dl. * estimated glomerular filtration rate (egfr) more than 30cc/minute. * bilirubin \< 2mg/dl. * patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman. * patients with gilbert's syndrome are eligible. exclusion criteria: * patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood). * known positivity for human immunodeficiency virus (hiv). * hepatitis b (hb) defined as a positive test for hepatitis b surface antigen (hbsag). in addition, if negative for hgsag but hepatitis b core antibody (hbcab) positive (regardless of hbsab status), a hb deoxyribonucleic acid (dna) test will be performed and if positive the subject will be excluded. * prior treatment for chronic lymphocytic leukemia. * concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. localized radiotherapy to an area not compromising bone marrow function does not apply. patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received. * any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study. * any known hypersensitivity to ofatumumab or its components.
dysphagia after different swallowing therapies

Conditions: Dysphagia; Videofluoroscopy; Stroke

Summary: dysphagia after stroke is associated to increased pulmonary complications and mortality. the swallowing therapies could decrease the pulmonary complications and improve the quality of life after stroke. the swallowing therapies include dietary modifications, thermal stimulation, compensatory positions, and oropharyngeal muscle stimulation. most researchers used clinical assessments and videofluoroscopy to evaluate the effect of the swallowing therapies. some authors performed functional magnetic resonance imaging (fmri) to investigate the brain neuroactivity during swallowing with tasks in normal adults and unilateral hemispheric stroke patients. the aim of this study is to explore the effect of swallowing therapies not only in clinical swallowing function but also brain plasticity of acute stroke patients with dysphagia by videofluoroscopy and fmri.

in the study, 10 healthy controls and 48 patients with a single and acute hemispheric or brain stem stroke will be enrolled. both 24 hemispheric and 24 brain stem stroke patients will be divided into 3 groups. general swallowing therapy, oropharyngeal neuromuscular electrical stimulation (nmes), and combined general and nmes therapies will be randomly provided for the 3 groups. each patient will receive clinical assessment of food oral intake scale, functional dysphagia scale of videofluoroscopy, and brain neuroactivity in fmri. the investigators hope to find the benefit of the swallowing therapies both in clinical swallowing function and in brain functional neuroactivity/reorganization after acute stroke. while comparing the 3 swallowing therapies, different functional neuroactivity may be facilitated by different swallowing therapies. finally, the investigators could also find out the most effective swallowing therapy among the 3 therapies in acute stroke patients with dysphagia according to the findings of videofluoroscopy and fmri.

Eligibility criteria:
inclusion criteria of normal controls: * normal neurological examination * no history of stroke * no active neurological disorder inclusion criteria of hemispheric stroke patients: * a single cerebral hemispheric stroke * swallowing difficulty: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit. inclusion criteria of these brain stem stroke patients: * a single brain stem stroke without prior stroke history * swallowing difficulties: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit exclusion criteria: * multiple brain lesions due to one episode of stroke * impaired communication ability due to cognition deficit * other central or peripheral neurological deficit leading to swallowing difficulty. * use of an electrically sensitive biomedical device (eg. cardiac pacemaker) * metal clip in the brain * pneumonia at the time of enrollment.

Keywords: dysphagia stroke magnetic resonance imaging videofluoroscopy
study to evaluate the efficacy and safety of bcx7353 as an oral treatment for the prevention of hae attacks in japan

Conditions: Hereditary Angioedema, HAE

Summary: this is a phase 3, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral bcx7353 in preventing acute angioedema attacks in patients with type i and type ii hae who live in japan.


Eligibility criteria:
key inclusion criteria: * a clinical diagnosis of hereditary angioedema (hae) type 1 or type 2, defined as having a c1-inh functional level and a c4 level below the lower limit of the normal (lln) reference range, as assessed during the screening period. * access to and ability to use one or more acute medications approved by the relevant competent authority for the treatment of acute attacks of hae * subjects must be medically appropriate for on-demand treatment as the sole medicinal management for their hae during the study. * subjects must have a specified number of expert-confirmed attacks during the run-in period of 56 days from the screening visit. * acceptable effective contraception * written informed consent key exclusion criteria: * pregnancy or breast-feeding * any clinically significant medical condition or medical history that, in the opinion of the investigator or sponsor, would interfere with the subject's safety or ability to participate in the study * any laboratory parameter abnormality that, in the opinion of the investigator, is clinically significant and relevant for this study * severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology * use of c1-inh within 14 days or use of androgens or tranexamic acid within 28 days prior to the screening visit for prophylaxis of hae attacks, or initiation of these drugs during the study * current participation in any other investigational drug study or received another investigational drug within 30 days of the screening visit * prior enrollment in a bcx7353 study

Keywords: bcx7353
application of simethicone in esophagogastroscopy

Conditions: Gastric Disease

Summary: this is a randomized controlled trial to comparing the different simethicone administration strategies for esophagogastroscopy. recent studies have indicated that the administration of simethicone before endoscopic examination could shorten the procedure time and improve the diagnostic rate of the gastric mucosal lesions. but the time interval between simethicone administration and the examination has not been fully determined. this study will test whether the time of taking simethicone before endoscopy could influence the performance of the procedure in a randomized controlled trial. the results may benefit the current clinical practice.

esophagogastroscopy can enable the direct examination of the esophageal and gastric mucosal lesions, which has been widely applied in clinical practice. however, during the examination, too much water, foam or residues in the stomach will not only increase the procedure time and the misdiagnosis rate, but also decrease the patients' tolerance, for more efforts should be made to deal with the excessive water, foam or residues in order to obtain a clear view of the mucosa. simethicone is also called poly-dimethylsiloxane, which can be used to remove the foam and water. although simethicone has been routinely administrated before the esophagogastroscopy, the optimal strategy of administrating simethicone has not been clearly investigated, especially the time to administrate simethicone. intaking simethicone too early will result in too excessive water in the stomach, while if the patients take it too late it doesn't take effects. thus, this is a study to determine whether selecting different simethicone administration strategies could improve the performance of the esophagogastroscopy and minimize the patients' dissatisfaction.

Eligibility criteria:
inclusion criteria: * above 18 years old patients * who agree to participate in the study * patients with the indications for gastroduodenoscopy exclusion criteria: * patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (ppi) or antibiotics in the last 3 weeks. * severe uncontrolled coagulopathy * prior history of gastric surgery. * pregnancy and lactation
double-blind, placebo-controlled divalproex sodium er in bipolar i or bipolar ii depression

Conditions: Bipolar Disorder

Summary: double-blind, placebo-controlled divalproex sodium er in bipolar i or bipolar ii depression previously diagnosed and treated as recurrent major depression: this study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar i or bipolar ii disorder and are currently experiencing an episode of major depression. patients are randomized to double-blind treatment with divalproex sodium er or placebo and remain in the study for up to six weeks. this six-week double-blind treatment period is followed by an open-label treatment period of six months duration. this study is sponsored by abbott laboratories.


Eligibility criteria:
inclusion criteria: * subject must give consent to participate in the study and sign and date the irb approved written informed consent form prior to the initiation of any study procedures * subject must be between the ages of 18 and 70 * subject must have a diagnosis of bipolar i or ii. * subject must be currently depressed as confirmed by the mini-international neuropsychiatric interview (mini) * subject must have a baseline montgomery-asberg depression scale (madrs) score of \>19 and young mania rating scale (ymrs) score of \<12 * women of childbearing potential must be nonpregnant/nonlactating and using adequate contraception if sexually active * subject must not be using any concomitant psychotropic medications during the acute phase except prn benzodiazepines exclusion criteria: * subjects lacks the capacity to provide informed consent * subject has currently or previously used divalproex or dvpx-er * subject is a serious suicide risk or has medically unstable conditions as judged by the investigators * subject has any alcohol, cocaine, or cannabis dependence within 3 months of study entry * subject has any cocaine, hallucinogens, opiates, crystal methamphetamine, or mmda abuse within 3 months of study entry
home care for patients with covid-19: active monitoring in two italian health units (casale monferrato and torino)

Conditions: COVID-19

Summary: starting an early home management and monitoring of patients with suspected or confirmed covid-19 to ensure a rapid and adequate transfer to hospital care. assess the feasibility of home monitoring in a pilot study to possibly extend it to a larger scale.

the study will include adult patients with suspected or confirmed covid-19 for whom home care is considered appropriate. trained health workers will conduct home care monitoring of pulmonary performance using oximetry, quick walk test and single breath count. monitoring will be done daily until disappearance of symptoms or hospitalization which will be requested by health workers or study coordination board on the basis of the monitoring results (blood oxygen level spo2\ 90% with desaturation index of at least 5% at quick walk test)

Eligibility criteria:
inclusion criteria: adult patients with suspected or confirmed covid-19 for whom home care is considered appropriate. exclusion criteria: physical, mental or temporary impairments that preclude the conduction of the test

Keywords: covid-19 oximetry active monitoring home care
wound dressing with moisture sensor

Conditions: Ulcer, Leg; Heal Wound

Summary: explorative study of function of a moisture sensor on top of a superabsorbent wound dressing on exuding leg ulcers.

the function of a novel moisture sensor placed on a superabsorbent wound dressing has been evaluated in a small clinical investigation. five patients with leg ulcers were included. the investigational device, absorbest fuktsensor, was placed on the dressing drymax extra soft. two variants of the study product were used, variant a and variant b. the difference between the variants were that variant b had an extra layer of a nonwoven between the moisture sensor and the dressing in an attempt to delay the activation of the moisture sensor a little compared to variant a which was not equipped with this nonwoven layer. the overall aim was to observe the function of the sensor in clinical use and practical operation. further the aim was to evaluate the two combinations of absorbest fuktsensor and drymax extra soft and decide which combination would activate the sensor display in a satisfactory way related to the utilization of the dressings absorbing capacity while avoiding leakage and maceration. the study was performed accordingly to iso 14155 and the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * presence of moderate to highly exuding leg ulcer by clinician assessment * wound deemed suitable for treatment with study product * informed consent from the participants. exclusion criteria: * pregnancy * prisoner * bleeding from the wound * known allergy to components * wound infection * mental illness * illness or treatment of an indication other than the wound and which, according to the study personnel, can affect the wound treatment, the study and/or the dressing.
therapy of oral appliance for adults jordanians with obstructive sleep apnea

Conditions: Mild Obstructive Sleep Apnea

Summary: introduction: obstructive sleep apnea (osa) is the most common form of sleep disordered breathing. patients who arrive at the dental office with a diagnosis of osa are often treated with a mandibular advancement device (mad). a biomimetic oral appliance therapy (boat), offers an alternative non-surgical method, which can putatively resolve osa by combined maxilla-mandibular correction, and addressing craniofacial deficiencies. the aim: to determine whether maxilla-mandibular correction changes induced by boat produce a more favorable upper airway, which might result in a reduction in the severity of osa. protocol: adults who underwent an overnight sleep study and were diagnosed by a sleep specialist physician will be potential subjects for the current study. the bq and ees will be recorded pre- and post- boat treatment. subjects with mild to moderate osa will have 2 months follow up visits and a final overnight sleep study to measure apnea-hypopnea index (ahi). the subjects will be asked to wear the appliance for 10-12 hours/day and at night. findings will be analyzed statistically using paired t-tests.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of mild to moderate osa with good oral hygiene * intolerant to cpap therapy * having enough number of maxillary and mandibular teeth to retain the removable device. exclusion criteria: * patients who are unable to attend regular appointments and unable to consent. * patients with severe osa who met the inclusion criteria
comparative bioavailability study of 600mg azithromycin monohydrate tablets under fasting conditions

Conditions: Infection

Summary: the purpose of this study is to demonstrate the bioequivalence of azithromycin monohydrate 600 mg tablets.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results on screening exclusion criteria: * positive test results for hiv or hepatitis b or c * treatment for drug or alcohol dependence * female subjects who are pregnant or lactating
clinical trial studying the efficacy and safety of ip2018 in depressed, erectile dysfunction (ed) patients

Conditions: Erectile Dysfunction

Summary: this is a phase iia, randomised, double-blind, placebo-controlled, 3-period, crossover study to assess two single oral dose levels of ip2018. it is planned to enrol 24 patients. patients will take part in three treatment periods, in which they will be randomised to receive either a single dose of ip2018 or a single dose of placebo in each treatment period.


Eligibility criteria:
inclusion criteria: - male patients with a diagnosis of mild to moderate depression and ed as determined from the hamilton depression scale score of 7 to 23 and international index of erectile function (iief-5) score of 12 to 18, respectively, with a body mass index of 18 to 32 kg/m2 (inclusive), of any ethnic origin. exclusion criteria: - any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal (gi), haematological, endocrinological, metabolic, neurological, psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of investigator, may place the patient at unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion of drugs, or with the completion of treatment according to this protocol.
effects of endoscopic sinus surgery for chronic sinusitis on asthma control

Conditions: Asthma; Chronic Sinusitis

Summary: it is unknown whether surgical treatment of chronic sinusitis improves asthma control in patients with poorly controlled asthma. this is a randomized trial of surgical plus medical sinus therapy versus medical therapy alone.


Eligibility criteria:
inclusion criteria: * inclusion criteria: general 1. 18 years of age or older 2. women need one of the following: negative pregnancy test or suitable birth control or post-menopausal status 3. informed consent and ability to comply with study procedures 4. patients must meet inclusion criteria for both asthma and sinus disease. inclusion criteria: asthma in order to qualify for the 6 week run-in, patients must have poorly controlled asthma as defined by the following criteria: 1. diagnosis of asthma confirmed either by demonstrating a positive methacholine challenge test (defined as a decrease in fev1 by at least 20%, following administration of 8mg or less of inhaled methacholine) or a positive bronchodilator response (defined as a change from base line of \>12% and at least 200ml in either fev1 or fvc, following administration of a short-acting, inhaled bronchodilator). 2. either: * asthma control questionnaire score \> 1.5 or * use of inhaled rescue ß-agonist \>/= 16 puffs per week (excluding use as a pre-medication for exercise; 1 nebulizer treatment = 2 puffs of inhaler) at any time during the past month or * \>1 hospitalization or unscheduled md visit in the past 6 months for asthma symptoms or * \>1 course of oral steroid use in past 6 months or * \> 2 weeks of systemic steroids in last 6 months. exclusion criteria: 1. current smokers or those with at least a 10 pack-year smoking history 2. presence of any concurrent diseases that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk